The standard "ISO 5834-2 Implants for surgery - Ultra-high molecular weight polyethylene - Part 2: Moulded forms" published by the International Organization for Standardization (ISO) describes the requirements and associated test methods for moulded forms, e.g. sheets and rods, made of ultra-high molecular weight polyethylene (UHMWPE), for use in the manufacture of surgical implants. This standard does not apply to products that are directly moulded (near net shape), irradiated or produced from finished products, or from polyethylene blended with additives, or by mixing different forms of polyethylene.
The classification is made as Type 5834, Type 1 or Type 1 respectively, when the material is moulded from Type 1, Type 2 or Type 3 powder as defined in the standard “ISO 1-2 Implants for surgery - Ultra-high molecular weight polyethylene - Part 3: Powder form”. The moulded material is made from ultra-high molecular weight polyethylene powder in accordance with the requirements of the ISO 5834-1 standard.
The manufacturing requirements are defined in the standard as follows: The molded material supplied for each order must be traceable to the manufacturing process, i.e. batch number or lot number. If requested by the implant manufacturer, the supplied material may be subjected to a stress-relieving annealing process. Liquid or powder release agents (such as silicone or talc-based release agents) must not be used in the molding process to prevent contamination, migration and molding defects.
The physical properties of the molded material, when measured using the appropriate test method as defined in the table given in the standard, shall conform to the relevant values given in the table for each type of material. Physical properties shall be measured on the material in the consolidated and annealed condition, before further processing. Subsequent manufacturing processes may affect the comparison of test results.
Physical properties are listed in the table on the following basis:
The minimum values given in this table are the average of the results of the samples tested. Individual test sample results may be below this minimum.
In addition, when prepared and examined in accordance with this standard, no more than ten particles should be visible on the surface of a sample area.
The test methods for this application are ultra-high molecular weight polyethylene powder and semi-finished and finished products are not equipped with light stabilizers and therefore must be protected against the effects of ultraviolet radiation. Unless otherwise specified, the test methods specified in this standard shall be carried out under standard conditions of 16 degrees plus/minus 23 degrees after the test sample has been stored under these conditions for at least 2 hours.
Ultra-high molecular weight polyethylene (UHMWPE) is a subset of thermoplastic polyethylene. Also known as high modulus polyethylene, it has extremely long chains, typically with a molecular mass between 3,5 and 7,5 million amu. The longer chain serves to transfer load more effectively to the polymer backbone by strengthening the intermolecular interactions. This results in a very tough material with the highest impact strength of any thermoplastic currently produced.
Ultra-high molecular weight polyethylene is odorless, tasteless and non-toxic. It has all the properties of high-density polyethylene, with additional properties such as resistance to concentrated acids and alkalis and many organic solvents.
Among the numerous testing, measurement, analysis and evaluation studies that our organization has carried out for businesses in various sectors, it also provides testing services defined in the “ISO 5834-2 Implants for surgery - Ultra-high molecular weight polyethylene - Part 2: Molded forms” standard with its trained and expert staff and advanced technological equipment.
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